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Raystation (2015-05-08)
- Starting date:
- May 8, 2015
- Posting date:
- June 15, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-53793
Recalled Products
- Raystation
Reason
An issue was found with the dose calculation for some imported VMAT plans where controls points are defined with wide gantry angle spacing. When VMAT control points are distributed with a wider gantry angle spacing than 4 degrees, the dose calculation will not be accurate.
Affected products
A. Raystation
Lot or serial number
- 3.5.0.16
- 4.0.1.4
- 4.0.3.4
Model or catalog number
- 3.5
- 4
Companies
- Manufacturer
-
Raysearch Laboratories AB,
Sveavagen 25,
Stockholm
11134
SWEDEN